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OsteoFlo HydroFiber is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. These defects may be surgically created or the result of traumatic injury to the bone. OsteoFlo HydroFiber is indicated to be packed gently into bony voids or gaps of the extremities, pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, OsteoFlo HydroFiber must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

The OsteoFlo® HydroFiber™ is a resorbable bone void filler designed to be placed in bony defects, either surgically created (i.e., tumor removal), or the result of traumatic injury. The single-use device is supplied sterile and dry. The device requires mixing with aqueous solution (autograft, saline, blood, or bone marrow aspirate) prior to use. OsteoFlo HydroFiber may be used as standalone, equivalent to autograft, in conjunction with autograft, or as a bone graft extender.

It appears there's a misunderstanding. The provided FDA 510(k) clearance letter for the OsteoFlo HydroFiber device is for a Resorbable Calcium Salt Bone Void Filler Device, which is a physical implantable device.

The request asks for information typically associated with AI/ML-based medical devices, particularly regarding:

• A table of acceptance criteria and reported device performance (often including metrics like sensitivity, specificity, AUC for AI models)
• Sample sizes for test sets, data provenance
• Expert involvement for ground truth establishment (e.g., radiologists for image interpretation)
• Adjudication methods
• Multi-reader multi-case (MRMC) studies
• Standalone performance (algorithm only) vs. human-in-the-loop performance
• Types of ground truth (e.g., pathology, outcomes data)
• Training set sample size and ground truth establishment

The provided FDA letter does not contain any information related to AI/ML software performance or studies. Instead, it lists non-clinical performance data for a physical medical device, such as:

• Biocompatibility
• Sterilization validation
• Packaging validation
• Shelf-life testing
• Endotoxin validation
• Material characterization
• Dimensional stability assessment
• In vivo evaluation (Rabbit Metaphyseal Defect Model)
• Pyrogenicity Testing

Therefore, I cannot fulfill your request based on the provided text, as the document describes the clearance of a physical bone void filler, not an AI/ML software device. The acceptance criteria and performance studies mentioned in the document are for the physical properties and biological interactions of an implantable material, not for the diagnostic or analytical performance of an AI algorithm.

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The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood.
The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.
The ALARA BMAC Needle is intended for use in harvesting core biopsy samples of cancellous bone and/or bone marrow.

The ALARA BMA Neuro Access Kit utilizes a neuromonitoring platform in providing the surgeon with nerve / root location feedback during the approach to a pedicle to support a guidewire placement.

The ALARA BMAN and ALARA BMAC Kit includes various single-use needles designed for bone marrow aspiration and aspiration of autologous blood.

This document is an FDA 510(k) clearance letter for a medical device called the "ALARA BMA Neuro Access Kit." This type of document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than presenting detailed study results for a new AI/ML-driven diagnostic device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML diagnostic. The "Performance Testing" section lists various engineering and material tests (e.g., torque, pull, strength, sterilization, biocompatibility) relevant to the physical components of the device, not performance metrics for an AI algorithm.

Here's why the requested information cannot be extracted from this document:

• No AI/ML Component: The device description and performance testing sections indicate a physical medical instrument (needles for biopsy, aspiration, and a neuromonitoring platform for "proximity feedback" during pedicle preparation). There is no mention of an AI or machine learning algorithm. The "proximity feedback" is likely an electrical or mechanical system, not an AI interpreting images or data.
• Focus on Substantial Equivalence: A 510(k) clearance is primarily about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often relies on comparing design, materials, intended use, and non-clinical performance (like the engineering tests listed). It does not typically involve the rigorous clinical efficacy studies or AI performance validation described in your prompt.
• Lack of Diagnostic Claims: The device is for "aspiration of bone marrow or autologous blood," "pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback," and "harvesting core biopsy samples." These are procedural/interventional uses, not diagnostic uses that would involve interpreting data (image, signal, etc.) with an AI.

In summary, as the provided document pertains to a physical medical device and not an AI/ML-driven diagnostic, the questions about acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI are not applicable to the content provided.

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The GraftGun Universal Graft Delivery System (GDS®) is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site, via direct visualization or minimally invasive.

The GraftGun Universal Graft Delivery System (GDS®) consists of a sterile, single-use, disposable device, and non-sterile reusable Adapter Tips intended for the delivery of prepared allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. The GraftGun Universal Graft Delivery System (GDS®) includes the GraftGun Dispensing Unit, Loading Device, Graft Tubes, and Adapter Tips.

The provided text describes a medical device, the GraftGun Universal Graft Delivery System (GDS®), and its 510(k) clearance process. However, this document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) system.

The device described is a piston syringe used for delivering bone graft material. The performance testing mentioned (Compatibility Assessments, Sterilization Validations, Cleaning Validations, Biocompatibility Assessment, Package Performance, Shelf-Life Testing) are standard tests for mechanical medical devices to ensure their safety, functionality, and sterility. They are not related to AI/ML performance metrics such as sensitivity, specificity, AUC, or reader studies.

Therefore, I cannot fulfill your request for the specific details about AI/ML acceptance criteria and study data based on the provided text. The document is for a non-AI/ML device.

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The TiLink-P Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint. The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments (sterile or non-sterile). The TiLink-P SI Joint Fusion System may be used via lateral or posterior oblique. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.

This document is a 510(k) premarket notification decision letter from the FDA to SurGenTec LLC for their TiLink-P SI Joint Fusion System. It states that the device has been determined to be substantially equivalent to legally marketed predicate devices.

Based on the provided text, the device discussed is NOT an AI/ML medical device. The document describes a physical medical device (components of a sacroiliac joint fusion system) and its mechanical, material, and biological performance testing.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment with experts) is not applicable to this submission.

The document discusses performance testing relevant to a physical implantable device, such as:

• Axial Pullout Testing per ASTM F543: This likely measures the force required to pull the implant out of bone, assessing its fixation strength.
• Static and Dynamic Cantilever Test per ASTM F3574: This assesses the implant's resistance to bending under various loading conditions, relevant for its structural integrity.
• Sterilization, Packaging, and Shelf-Life Validations: These ensure the device remains sterile and functional over time.
• Biocompatibility Assessment per ISO 10993: This confirms the materials used in the device are safe for contact with human tissue.

The "acceptance criteria" for these tests would be specific parameters and thresholds (e.g., minimum pullout force, maximum deflection under load) defined by the manufacturer and often guided by relevant ASTM/ISO standards. The "study" proving it meets these criteria would be the results of the physical tests.

Since the prompt specifically asks for details relevant to an AI/ML device, and this document does not pertain to AI/ML, I cannot provide the requested information in that context.

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OsteoFlo HydroFiber is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure i.e., the pelvis, intervertebral disc space, and posterolateral spine. These defects may be surgically created or the result of traumatic injury to the bone. OsteoFlo HydroFiber is indicated to be packed gently into bony voids or gaps of the pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed with host bone during the healing process. When used in intervertebral body fusion procedures. OsteoFlo HydroFiber must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

OsteoFlo HydroFiber is a resorbable bone void filler comprised of calcium phosphate, bioglass, in a synthetic polymer binder. The OsteoFlo HydroFiber is intended to be easily packed into osseous defects. The single-use device is supplied sterile and dry. The device requires mixing with aqueous solution (autograft, saline, or bone marrow aspirate) prior to use. OsteoFlo HydroFiber may be used as standalone, equivalent to autograft, or in conjunction with autograft.

The provided text is a 510(k) summary for the OsteoFlo HydroFiber device. It outlines the device's indications, description, and comparison to predicate devices, focusing on demonstrating substantial equivalence based on non-clinical performance testing.

However, the document does not contain any information regarding clinical studies or the performance of an AI/software device. Therefore, I cannot provide details on acceptance criteria, expert adjudication, MRMC studies, standalone performance, or ground truth establishment as requested.

The document primarily focuses on non-clinical performance testing for a bone void filler, which includes:

• Biocompatibility per ISO 10993-1:2018
• Sterilization validation per ISO 11137-1:2006 and ISO 11137-2:2013
• Packaging validation per ISO 11607-1:2009 and ISO 11607-2:2006
• Shelf-life testing per ASTM 1980-16
• Material characterization (x-ray diffraction, particle size, particle porosity and surface area)
• In vivo evaluation in a Lapine Posterolateral Fusion Model

Without information regarding an AI/software component or human reader studies, I cannot fill out the requested table or answer the specific questions related to AI device performance.

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The Ion 3D Facet Screw may be used in conjunction with the Ion 3D GraftRasp to perform posterior spinal fusion. The Ion 3D GraftRasp may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of hydrated allograft or autograft. The Ion 3D Facet Screw is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:

• · Spondylolisthesis
• · Spondvlolysis
• · Pseudoarthrosis or failed previous fusions which are symptomatic
  · Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability
  The Ion 3D Facet Screw is intended for use with bone graft material (allograft, or autograft).

The Ion 3D contains various sized facet screws with and without graft windows for bilateral stabilization of the facets from C2-S1. The Ion 3D is provided in various configurations, including single-use, and reusable. The Instruments are offered in sterile and non-sterile configurations. All implants are manufactured from Ti6Al4V per ASTM F136.
The purpose of this 510(k) is to add new Ion 3D Facet Screws and new instruments to the system.

The provided text is a 510(k) Pre-market Notification summary for a medical device (Ion 3D Facet Screw) and does not describe a clinical study with an AI component or detailed performance criteria in the way a diagnostic AI device would. Instead, it focuses on demonstrating substantial equivalence to predicate devices through engineering justifications and non-clinical performance testing.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable or available within this document.

Here's a breakdown of the information that can be extracted and a clear indication of what is not present:

1. Table of acceptance criteria and reported device performance:

The document doesn't provide specific numerical acceptance criteria or performance metrics in a table format as would be seen for a diagnostic AI device. Instead, it relies on demonstrating that the device's mechanical performance is not "worst-case" compared to predicates and that it meets standards for biocompatibility and sterilization.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as it focuses on non-clinical testing (mechanical, biocompatibility, sterilization, cleaning) rather than a clinical performance study with test data. The "test set" here refers to the physical devices and materials tested.
• Data Provenance: Not applicable. The testing is primarily laboratory-based and simulated.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

• Not applicable. Ground truth as typically understood for AI or diagnostic devices (e.g., expert consensus on pathology images) is not relevant to this type of mechanical and material testing. The "ground truth" for these tests would be the established scientific and engineering principles and standards (e.g., ISO 10993).

4. Adjudication method for the test set:

• Not applicable. There is no mention of adjudication, as this type of testing does not involve subjective expert review for establishing ground truth from clinical data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, ‭If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. An MRMC study was not conducted. This device is a surgical implant (facet screw) and associated instruments, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No. This device is a physical implant and surgical tools; there is no standalone algorithm to evaluate.

7. The type of ground truth used:

• For mechanical performance: Engineering principles and simulation models (Finite Element Analysis) as surrogate for clinical performance under defined loads.
• For biocompatibility: International standard ISO 10993.
• For sterilization and cleaning: Industry-accepted validation protocols and standards.

8. The sample size for the training set:

• Not applicable. This document refers to a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. No training set is involved for this type of device submission.

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The TiLink-P Joint Fusion System is intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint. The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink-P SI Joint Fusion System fixates the sacroiliac joint by transfixing the cortices of the ilium and cortices of the sacrum.

The TiLink-P Compression Anchor is positioned so that it spans the cortices of ilium and cortices of sacrum, the TiLink-P Locking Screw is inserted through the TiLink-P Compression Anchor and across the SI Joint via a lateral approach, compressing the joint. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "TiLink-P Joint Fusion System." The purpose of these notifications is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective.

The type of "device" in question here is a system of orthopedic implants and instruments used for sacroiliac joint fusion. This is a physical medical device, not software or an AI algorithm. Therefore, the questions related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/software device do not apply to this document.

The document describes performance testing for the physical device, which involves mechanical tests to ensure its structural integrity and functionality, rather than clinical performance based on an AI model's output.

Here's why the AI/software-related questions cannot be answered from this document:

• No AI or Software Component: The 510(k) summary explicitly describes the TiLink-P Joint Fusion System as "various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant" and "TiLink Implants and associated Instruments." There is no mention of any AI, machine learning, or software component that would require assessment of diagnostic accuracy, image performance, or human-AI collaboration.
• Focus on Substantial Equivalence: The entire premise of a 510(k) is to prove substantial equivalence to a predicate device. This typically involves comparing indications for use, technological characteristics, materials, and mechanical performance for physical devices. It does not involve evaluating "device performance" in terms of diagnostic accuracy or impact on human readers, which are typical for AI/software clearances.
• Performance Testing Summary: The "Performance Testing Summary" lists "Axial Pullout Testing per ASTM F543," "Torsional Properties per ASTM F543-17," and "Static and Dynamic Cantilever Test per ASTM F3574." These are all standard mechanical tests for orthopedic implants, ensuring they can withstand physiological loads. They are not studies of algorithm performance.

Therefore, I cannot provide answers to the questions you've asked because they are tailored for AI/software-based medical devices, and the provided document describes a physical orthopedic implant system.

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The TiLink-P SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The purpose of this Special 510(k) is to introduce the TiLink-P with Window variant to the TiLink-P SI Joint Fusion System. The Window feature is designed to promote osteointegration.

The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint. The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink-P implants may be used standalone. The TiLink-P SI Joint Fusion System fixates the sacroiliac joint by transfixing the cortices of the ilium and cortices of the sacrum.

The TiLink-P Compression Anchor is positioned so that it spans the cortices of ilium and cortices of sacrum, the TiLink-P Locking Screw is inserted through the TiLink-P Compression Anchor and along the SI Joint via a posterior approach, in order to compress the joint. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.

The FDA letter provided is a clearance letter for a medical device (TiLink-P SI Joint Fusion System), not an AI/ML device. Therefore, the document does not contain information about acceptance criteria or studies pertaining to AI/ML device performance. The information requested regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data is not applicable to the content of this document.

The document discusses the substantial equivalence of the "TiLink-P SI Joint Fusion System" to a predicate device (TiLink-P Joint Fusion System K240720) through mechanical strength tests.

Here is the information that is available in the document:

1. A table of acceptance criteria and the reported device performance

The document states that performance testing was conducted according to specific ASTM standards to demonstrate substantial equivalence to the predicate device. However, it does not provide a table of acceptance criteria (e.g., specific thresholds for pullout strength or shear strength) nor the reported numerical performance data. It only lists the types of tests performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The "test set" here refers to physical devices for mechanical testing, not a dataset for an AI/ML model. The document does not specify the number of devices tested. Data provenance such as country of origin or retrospective/prospective is not relevant for this type of device clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth as typically understood in AI/ML (e.g., expert labels on images) is not relevant for this type of mechanical device testing. The "ground truth" for mechanical testing is derived from established engineering principles and ASTM standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used for resolving disagreements among human experts in labeling datasets, which is not relevant for mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a clearance for a physical medical implant, not an AI/ML diagnostic or assistive device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For mechanical testing, the "ground truth" is provided by the established ASTM standards and the physical properties and performance of the predicate device.

8. The sample size for the training set

Not applicable. There is no AI/ML model, and therefore no training set.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML model, and therefore no training set or ground truth for a training set.

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The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood.

The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.

The ALARA BMA Neuro Access Kit utilizes a neuromonitoring platform in providing the surgeon with nerve / root location feedback during the approach to a pedicle to support a guidewire placement.

The ALARA BMAN and ALARA BMAC Kit includes various single-use needles designed for bone marrow aspiration and aspiration of autologous blood.

The provided text describes the regulatory clearance of the ALARA BMA Neuro Access Kit, focusing on its substantial equivalence to predicate devices based on design, materials, and non-clinical testing. However, it does not include acceptance criteria, reported device performance, or details of a study that proves the device meets specific performance criteria.

Therefore, I cannot populate the table or answer questions 2 through 9 based on the provided document. The document primarily focuses on regulatory approval based on comparison to existing legally marketed devices, rather than a detailed performance study against predefined acceptance criteria.

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